Neo-TACE-HAIC for BCLC B Stage HCC (NeoconceptB)

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Sun Yat-sen University

Status

Enrolling

Conditions

Hepatocellular Carcinoma

Treatments

Procedure: Surgery alone
Procedure: neo-TACE-HAIC+Surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT04424043
B2020-127

Details and patient eligibility

About

Hepatocellular carcinoma (HCC) patients is a common disease in the East Asia. Although BCLC (Barcelona clinical liver cancer) system recommend to transarterial chemoembolization (TACE) for BCLC B stage patients, increasing studies suggested that hepatic resection provided survival benefit for those patients. However, a relative high recurrence risk leads surgeons to investigate the value of preoperative treatment. Recently, FOLFOX (Oxaliplatin and 5-fluorouracil) based hepatic artery infusion chemotherapy (HAIC) exhibited high response rate for unresectable HCC. Pilot study showed TACE combined HAIC (TACE-HAIC) had better tumor response, with low progression disease rate. Whether TACE-HAIC would improve survival for patients with BCLC B stage is need to further to study. A randomized clinical trial compared neo-TACE-HAIC with surgery versus surgery alone is aimed to answer this question.

Enrollment

280 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • • Age 18-75 years;

    • BCLC B stage and tumor number <=4;
    • Patients with resectable primary hepatocellular carcinoma;
    • Child-Pugh A or B (7 score) liver function;
    • The volume of residual liver more than 30%

Exclusion criteria

  • • With unresectable HCC

    • Pregnant woman or sucking period;
    • With other malignant cancer;
    • Received anti-HCC therapy before this study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

280 participants in 2 patient groups

neo-TACE-HAIC with surgery
Experimental group
Description:
transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h +5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection
Treatment:
Procedure: neo-TACE-HAIC+Surgery
surgery alone
Active Comparator group
Description:
hepatic resection remove the liver tumors
Treatment:
Procedure: Surgery alone

Trial contacts and locations

1

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Central trial contact

Jiliang Qiu, MD.

Data sourced from clinicaltrials.gov

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